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Efficacy and Safety, Long-Term Study of NPC-16 to Treat Dysmenorrhea

Primary Purpose

Dysmenorrhea

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
NPC-16 Standard Dosing Regimen Group
NPC-16 Continuous Dosing Regimen Group
Placebo Group
Sponsored by
Nobelpharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • dysmenorrhea

Exclusion Criteria:

  • severe hepatopathy
  • pregnant woman

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    NPC-16 Standard Dosing Regimen Group

    NPC-16 Continuous Dosing Regimen Group

    Placebo Group

    Arm Description

    Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg

    Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg

    Placebo for NPC-16

    Outcomes

    Primary Outcome Measures

    Patient Response to Treatment for Dysmenorrhea, as Evaluated by Total Dysmenorrhea Score

    Secondary Outcome Measures

    Patient Response to Treatment for Dysmenorrhea, as Evaluated by Visual Analogue Scale (VAS) of Dysmenorrhea

    Full Information

    First Posted
    February 9, 2015
    Last Updated
    April 14, 2019
    Sponsor
    Nobelpharma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02362711
    Brief Title
    Efficacy and Safety, Long-Term Study of NPC-16 to Treat Dysmenorrhea
    Official Title
    Phase3, Placebo Controlled, Randomized, Double-blinded, Long-Term, NSAID-Add-on, Clinical Trial of NPC-16 for Treatment of Dysmenorrhea
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (Actual)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    January 28, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nobelpharma

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this long-term study is to determine whether NPC-16 is effective in the treatment of dysmenorrhea.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dysmenorrhea

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    248 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    NPC-16 Standard Dosing Regimen Group
    Arm Type
    Experimental
    Arm Description
    Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg
    Arm Title
    NPC-16 Continuous Dosing Regimen Group
    Arm Type
    Experimental
    Arm Description
    Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg
    Arm Title
    Placebo Group
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo for NPC-16
    Intervention Type
    Drug
    Intervention Name(s)
    NPC-16 Standard Dosing Regimen Group
    Other Intervention Name(s)
    Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg
    Intervention Type
    Drug
    Intervention Name(s)
    NPC-16 Continuous Dosing Regimen Group
    Other Intervention Name(s)
    Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo Group
    Other Intervention Name(s)
    Placebo for NPC-16
    Primary Outcome Measure Information:
    Title
    Patient Response to Treatment for Dysmenorrhea, as Evaluated by Total Dysmenorrhea Score
    Time Frame
    52 weeks
    Secondary Outcome Measure Information:
    Title
    Patient Response to Treatment for Dysmenorrhea, as Evaluated by Visual Analogue Scale (VAS) of Dysmenorrhea
    Time Frame
    52 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: dysmenorrhea Exclusion Criteria: severe hepatopathy pregnant woman
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tasuku Harada, MD, PhD
    Organizational Affiliation
    Tottori University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Mikio Momoeda, MD, PhD
    Organizational Affiliation
    St. Luke's International Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety, Long-Term Study of NPC-16 to Treat Dysmenorrhea

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